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Subacromial Impingement SyndromeNCT07536009

"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"

A study testing Digital Physical Therapy (Telerehabilitation) and Conventional Physical Therapy in people with Subacromial Impingement Syndrome, run by Instituto Mexicano del Seguro Social.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of this prospective, randomized, parallel-group, single-center, controlled non-inferiority clinical trial is to determine whether a telerehabilitation program is non-inferior to a conventional rehabilitation program in patients with subacromial pain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Subacromial Impingement Syndrome
What is being tested?
Digital Physical Therapy (Telerehabilitation) and Conventional Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
No sites listed yet
Study dates
15 Apr 2026to 30 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women aged 18 years or older.
  • Diagnosis of Subacromial Impingement Syndrome (SIS) based on clinical criteria (pain with overhead activities, painful arc, positive Neer, Hawkins, or Jobe test). Radiological confirmation (ultrasound and/or magnetic resonance imaging) is accepted.
  • Access to the internet and a device (smartphone, tablet, or computer) capable of running the telerehabilitation platform.
  • Willingness and ability to provide written informed consent.

Who cannot join

  • Shoulder pain caused by fractures, tumors, infections, or severe systemic pathologies.
  • Previous surgery on the affected shoulder within the last 3 months.
  • Prior joint injection (corticosteroid infiltration) in the affected shoulder within the last 3 months.
  • Subjects with partial or full-thickness rotator cuff tears.
  • Patients currently receiving concurrent physical therapy (PT) or any other external interventions for the shoulder condition.
  • Current participation in another rehabilitation or exercise program.
  • Pregnancy.
  • Cognitive impairment, communication barriers, or any condition that prevents the patient from following the remote instructions.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Roberto Carlos Pech Argüelles, MD contact

9991520786

drrobertopech@hotmail.com

About this study

The purpose of this prospective, randomized, parallel-group, single-center, controlled non-inferiority clinical trial is to determine whether a telerehabilitation program is non-inferior to a conventional rehabilitation program in patients with subacromial pain. Subacromial pain is a prevalent musculoskeletal condition, and while therapeutic exercise is the cornerstone of conservative management, adherence to home programs is often low. Conversely, conventional in-person physical therapy presents logistical and economic barriers for patients. This study aims to evaluate if a well-designed telerehabilitation program, utilizing information and communication technologies for remote monitoring, can provide an effective, accessible, and non-inferior alternative to conventional care. The primary outcome measured will be the change in shoulder function utilizing the QuickDASH questionnaire at 12 weeks. Secondary outcomes will assess pain intensity (VAS), range of motion (ROM), treatment adherence, and long-term functional outcomes.

Read the detailed description

Chronic subacromial pain represents a significant public health challenge and the most common musculoskeletal disorder after back and neck pain. Its etiology is multifactorial, causing substantial functional limitations, work disability, and a decrease in quality of life. The management of subacromial pain is primarily conducted through conservative interventions, with therapeutic exercise constituting the cornerstone of treatment to reduce joint pain, optimize shoulder function, and improve muscle strength.

Despite its efficacy, adherence to home exercise programs is often low due to a lack of supervision and motivation, which compromises long-term outcomes. While supervised, conventional in-person physical therapy improves adherence and functional outcomes, it presents significant logistical and economic barriers, such as travel costs, distance, and difficulty accommodating appointments within work schedules. This creates a gap in care, preventing many patients from receiving the necessary amount of therapy for optimal recovery.

Telerehabilitation, a remote healthcare delivery modality utilizing information and communication technologies, emerges as a promising solution to mitigate these barriers. Assisted digital therapy programs can be utilized to maximize treatment intensity, provide real-time biofeedback, and allow physical therapists to progressively adjust exercise complexity under remote guidance. This approach can potentially improve treatment adherence and reduce indirect costs for patients by eliminating travel needs and decreasing time off work.

Although current evidence provides compelling data regarding the efficacy of telerehabilitation, establishing its superiority over static home exercise programs, there is a lack of standardized protocols. Furthermore, a clear consensus has not been established regarding its non-inferiority to the conventional in-person model within a standard, non-pandemic clinical setting.

To address this gap, this study proposes a prospective, randomized, parallel-group, single-center, controlled non-inferiority clinical trial. The primary objective is to compare the change in shoulder function, as measured by the QuickDASH, at the end of a 12-week program between a telerehabilitation group and a conventional rehabilitation group. Secondary objectives include comparing changes in pain intensity (VAS) and range of motion (flexion, abduction, and external rotation), as well as evaluating treatment adherence, patient satisfaction, and long-term functional outcomes at 6 months. Answering this question will lay the groundwork for establishing a standardized, evidence-based telerehabilitation protocol as a highly accessible and sustainable care modality for patients with subacromial pain.

Being tested
Digital Physical Therapy (Telerehabilitation), Conventional Physical Therapy
Keywords
Telerehabilitation, Shoulder Pain, Subacromial Impingement Syndrome, Exercise Therapy, Physical Therapy Modalities
Medical subject headings
Shoulder Impingement Syndrome, Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Physical Therapy (Telerehabilitation)Other

    Multimodal digital intervention delivered via the Moodle platform. It includes a structured therapeutic exercise program (mobility, stretching, and progressive strengthening of rotator cuff and periscapular muscles), asynchronous remote monitoring by a physical therapist, and digital health education. Cognitive-behavioral therapy (CBT) components focused on pain reconceptualization and coping strategies are also integrated. Patients perform 30-minute daily sessions, 3-4 times per week, for a duration of 12 to 24 weeks.

  • Conventional Physical TherapyOther

    Standard in-person rehabilitation program conducted at the clinic. The intervention consists of supervised therapeutic exercises (similar to the experimental group), manual therapy techniques (joint mobilization and soft tissue manipulation as clinically indicated), and verbal health education provided by the physical therapist. Patients attend 2-3 in-person sessions per week, each lasting 30 minutes, for 12 to 24 weeks, complemented by printed home exercise instructions.

Study groups in NCT07536009
Study groupRoleWhat they receive
TelerehabilitationExperimentalA 12- to 24-week digital intervention program including a structured exercise protocol, health education, and cognitive-behavioral therapy (CBT) delivered via the Moodle platform. Exercises focus on mobility, stretching, and gradual strengthening of the shoulder/scapular muscles, recommended 3-4 sessions per week (30 minutes daily).
Receives: Other: Digital Physical Therapy (Telerehabilitation)
Conventional RehabilitationActive comparatorHigh-dose, in-person physical therapy at the clinic. The program includes therapeutic exercises with graded exposure to movement, manual therapy, and verbal education. Recommended 2-3 in-person sessions per week (30 minutes per session), complemented by home exercises.
Receives: Other: Conventional Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Shoulder Function

    Measured by the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH). The QuickDASH is an 11-item self-report questionnaire that measures physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. Scores range from 0 to 100, where 0 indicates no disability (best outcome) and 100 indicates the most severe disability (worst outcome).

    Measured: Baseline, 12 and 24 weeks

Secondary outcomes (5)
  1. Change in Pain Intensity

    Measured by the Visual Analog Scale (VAS). Participants rate their subjective intensity of pain on a continuous line or numeric rating scale. Scores range from 0 to 10, where 0 indicates "no pain" (best outcome) and 10 indicates the "worst imaginable pain" (worst outcome).

    Measured: Baseline, 12 and 24 weeks

  2. Change in Range of Motion (ROM)

    Measurement of active and passive range of motion of the affected shoulder using a clinical goniometer. The assessment includes the measurement in degrees of forward flexion, abduction, external rotation, and internal rotation. An increase in degrees indicates an improvement in mobility (better outcome).

    Measured: Baseline, 12 and 24 weeks

  3. Treatment Adherence

    Defined as the degree to which the participant complies with the prescribed exercise plan. It is calculated as the percentage (%) of completed exercise sessions relative to the total number of scheduled sessions. For the telerehabilitation group, adherence is derived from the Moodle platform metrics (login days, resources accessed, time spent). For the control group, it is manually recorded via the physical therapist's log.

    Measured: Baseline, 12 and 24 weeks

  4. Patient Satisfaction

    Participant's level of conformity or satisfaction with the assigned rehabilitation program. It is assessed using a numeric rating scale ranging from 0 to 10, where 0 indicates "completely dissatisfied" (worst outcome) and 10 indicates "extremely satisfied" (best outcome).

    Measured: Baseline, 12 and 24 weeks

  5. Long-Term Shoulder Function

    Long-term functional outcomes evaluated using the QuickDASH questionnaire. Scores range from 0 to 100, where 0 indicates no disability (best outcome) and 100 indicates the most severe disability (worst outcome).

    Measured: 24 weeks postintervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2026
  2. Study start15 Apr 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07536009
Sponsor's protocol ID
R-2026-3201-029
Other IDs
FMED-001446
Status last verified
Apr 2026
First submitted
9 Apr 2026
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Petersson AH, Bjornsson Hallgren HC, Adolfsson LE, Holmgren TM. No need for subacromial decompression in responders to specific exercise treatment: a 10-year follow-up of a randomized controlled trial. J Shoulder Elbow Surg. 2025 Jun;34(6):e477-e487. doi: 10.1016/j.jse.2024.10.027. Epub 2024 Dec 21.

    PubMed 39716615
  • Sheth U, Nam D, Richards R, Palinkas V, Wainwright A, Dunn PC, Razmjou H. Agreement on clinical examination and management between virtual videoconferencing and in-person assessment in a tertiary shoulder center. JSES Int. 2025 Jan 28;9(3):859-863. doi: 10.1016/j.jseint.2024.12.021. eCollection 2025 May.

    PubMed 40486802
  • Martinez-Rico S, Lizaur-Utrilla A, Sebastia-Forcada E, Vizcaya-Moreno MF, de Juan-Herrero J. The Impact of a Phone Assistance Nursing Program on Adherence to Home Exercises and Final Outcomes in Patients Who Underwent Shoulder Instability Surgery: A Randomized Controlled Study. Orthop Nurs. 2018 Nov/Dec;37(6):372-378. doi: 10.1097/NOR.0000000000000501.

    PubMed 30451774
  • Kane LT, Thakar O, Jamgochian G, Lazarus MD, Abboud JA, Namdari S, Horneff JG. The role of telehealth as a platform for postoperative visits following rotator cuff repair: a prospective, randomized controlled trial. J Shoulder Elbow Surg. 2020 Apr;29(4):775-783. doi: 10.1016/j.jse.2019.12.004.

    PubMed 32197766
  • Sabbagh R, Shah N, Jenkins S, Macdonald J, Foote A, Matar R, Steffensmeier A, Grawe B. The COVID-19 pandemic and follow-up for shoulder surgery: The impact of a shift toward telemedicine on validated patient-reported outcomes. J Telemed Telecare. 2023 Jul;29(6):484-491. doi: 10.1177/1357633X21990997. Epub 2021 Feb 1.

    PubMed 33525951
  • Huang T, Zhang W, Yan B, Liu H, Girard O. Comparing Telerehabilitation and Home-based Exercise for Shoulder Disorders: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2024 Nov;105(11):2214-2223. doi: 10.1016/j.apmr.2024.02.723. Epub 2024 Mar 2.

    PubMed 38432330
  • Zhang B, Fang Z, Nian K, Sun B, Ji B. The effects of telemedicine on Rotator cuff-related shoulder function and pain symptoms: a meta-analysis of randomized clinical trials. J Orthop Surg Res. 2024 Aug 14;19(1):478. doi: 10.1186/s13018-024-04986-4.

    PubMed 39143625
  • Pak SS, Janela D, Freitas N, Costa F, Moulder R, Molinos M, Areias AC, Bento V, Cohen SP, Yanamadala V, Souza RB, Correia FD. Comparing Digital to Conventional Physical Therapy for Chronic Shoulder Pain: Randomized Controlled Trial. J Med Internet Res. 2023 Aug 18;25:e49236. doi: 10.2196/49236.

    PubMed 37490337
  • Gutierrez-Espinoza H, Araya-Quintanilla F, Cereceda-Muriel C, Alvarez-Bueno C, Martinez-Vizcaino V, Cavero-Redondo I. Effect of supervised physiotherapy versus home exercise program in patients with subacromial impingement syndrome: A systematic review and meta-analysis. Phys Ther Sport. 2020 Jan;41:34-42. doi: 10.1016/j.ptsp.2019.11.003. Epub 2019 Nov 6.

    PubMed 31726386
  • Gava V, Ribeiro LP, Barreto RPG, Camargo PR. Effectiveness of physical therapy given by telerehabilitation on pain and disability of individuals with shoulder pain: A systematic review. Clin Rehabil. 2022 Jun;36(6):715-725. doi: 10.1177/02692155221083496. Epub 2022 Mar 1.

    PubMed 35230167
  • Correia FD, Molinos M, Luis S, Carvalho D, Carvalho C, Costa P, Seabra R, Francisco G, Bento V, Lains J. Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Mar 1;101(3):237-249. doi: 10.1097/PHM.0000000000001780.

    PubMed 33935152
  • Kromer TO, Kohl M, Bastiaenen CHG. Factors predicting long-term outcomes following physiotherapy in patients with subacromial pain syndrome: a secondary analysis. BMC Musculoskelet Disord. 2024 Jul 24;25(1):579. doi: 10.1186/s12891-024-07686-6.

    PubMed 39048996
  • Lafrance S, Charron M, Dube MO, Desmeules F, Roy JS, Juul-Kristensen B, Kennedy L, McCreesh K. The Efficacy of Exercise Therapy for Rotator Cuff-Related Shoulder Pain According to the FITT Principle: A Systematic Review With Meta-analyses. J Orthop Sports Phys Ther. 2024 Aug;54(8):499-512. doi: 10.2519/jospt.2024.12453.

    PubMed 38848304
  • Paavola M, Kanto K, Ranstam J, Malmivaara A, Inkinen J, Kalske J, Savolainen V, Sinisaari I, Taimela S, Jarvinen TL; Finnish Shoulder Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators. Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: a 5-year follow-up of a randomised, placebo surgery controlled clinical trial. Br J Sports Med. 2021 Jan;55(2):99-107. doi: 10.1136/bjsports-2020-102216. Epub 2020 Oct 5.

    PubMed 33020137
  • Back M, Paavola M, Aronen P, Jarvinen TLN, Taimela S; Finnish Shoulder Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators. Return to work after subacromial decompression, diagnostic arthroscopy, or exercise therapy for shoulder impingement: a randomised, placebo-surgery controlled FIMPACT clinical trial with five-year follow-up. BMC Musculoskelet Disord. 2021 Oct 19;22(1):889. doi: 10.1186/s12891-021-04768-7.

    PubMed 34666734

Questions about this trial

What is this clinical trial studying?

A study testing Digital Physical Therapy (Telerehabilitation) and Conventional Physical Therapy in people with Subacromial Impingement Syndrome, run by Instituto Mexicano del Seguro Social.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Roberto Carlos Pech Argüelles, MD (9991520786, drrobertopech@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Shoulder Function (time frame: Baseline, 12 and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07536009, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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Clinical Trial NCT07536009 | AzTrials